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Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

NCT ID: NCT01473251

Last Updated: 2014-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-04-30

Brief Summary

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The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

Detailed Description

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Conditions

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Exudative Macular Degeneration Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Avastin for Diabetic Macular Edema

1.25 mg avastin monthly for 4 months

Group Type ACTIVE_COMPARATOR

Avastin

Intervention Type DRUG

1.25 mg monthly for 4 months

Avastin for Exudative Macular Degeneration

1.25 mg Avastin monthly for 4 months

Group Type ACTIVE_COMPARATOR

Avastin

Intervention Type DRUG

1.25 mg monthly for 4 months

Lucentis for Exudative Macular Degeneration

0.5 mg Lucentis monthly for 4 months

Group Type ACTIVE_COMPARATOR

Lucentis

Intervention Type DRUG

0.5 mg monthly for 4 months

Interventions

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Avastin

1.25 mg monthly for 4 months

Intervention Type DRUG

Avastin

1.25 mg monthly for 4 months

Intervention Type DRUG

Lucentis

0.5 mg monthly for 4 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female age 18 to 85 with diabetes and hemoglobin A1C \</= 10, or exudative macular degeneration.
* Diabetic macular edema with average retinal thickness central subfield \>/= 290um.

Exclusion Criteria

* Macular atrophy/fibrosis.
* Ocular anti-VEGF treatment within 3 months.
* Treatment with topical or oral carbonic-anhydrase inhibitor within one month
* Laser photocoagulation within 3 months (diabetic cohort)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Van Andel Research Institute

OTHER

Sponsor Role collaborator

Vitreo-Retinal Associates, Michigan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Louis C. Glazer, MD

Role: PRINCIPAL_INVESTIGATOR

Vitreo Retinal Associates

Locations

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Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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VARI 2011 002

Identifier Type: -

Identifier Source: org_study_id